The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Hilaris-nori Endometrial Applicator.
| Device ID | K871216 |
| 510k Number | K871216 |
| Device Name: | HILARIS-NORI ENDOMETRIAL APPLICATOR |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. P.O. BOX 99 Bronx, NY 10465 |
| Contact | Felix W Mick |
| Correspondent | Felix W Mick MICK RADIO-NUCLEAR INSTRUMENTS, INC. P.O. BOX 99 Bronx, NY 10465 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-26 |
| Decision Date | 1987-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817339922776 | K871216 | 000 |
| 00817330022776 | K871216 | 000 |